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-   -   Dascor Clinical Trial (http://www.ispine.org/forum/ispine/314-dascor-clinical-trial.html)

wilsonrob 02-09-2007 02:30 PM

Dascor Clinical Trial
 
Does anyone know which surgeons in the USA are invloved in this trial? Is Dr. Bertagnoli involved in Germany?

Thanks

mmglobal 02-09-2007 05:32 PM

Here is an article from www.abc7.com regarding a Dr. Regan Dascor patient:


New Back Pain Procedure

February 8, 2007 - For nearly six years, a damaged disk on Sue Henriquez's lower spine caused her excruciating pain.

"It was hard to sit, it was hard to stand, hard to live basically," Henriquez said.
It made her job as a flight attendant nearly impossible especially when it came to baggage.

"I would actually ask other passengers or ask another flight attendant to come help me," Henriquez said.

Epidurals, acupuncture and physical therapy all failed. Her next option - a spinal fusion. But, orthopedic surgeon Dr. John Regan thought she was a good candidate for an "experimental" balloon angioplasty-like procedure for the back.

"The difference is we leave the balloon in and we don't do that in angioplasty," Dr. Regan said.

It's all done through a small incision, a catheter is snaked in to remove the damaged nucleus of the disk.

"And then we're putting a balloon in and inflating it with a polymer that's sort of a rubber consistency," Dr. Regan said.

The balloon helps stabilize the spine.

"Just because technology is new does not mean it is absolutely the best or needs to be put in," Dr. Ian Armstrong, of the Southern California Spine Institute, said.

Dr. Armstrong says new procedures give patients more choices, but always do your homework before you agree to be part of a study.

"Very valid questions to ask ... how many have been done, how long, success rates, complication rates," Dr. Armstrong said.

Dr. Regan says early studies on disc arthroplasty show long term benefits for most patients.

"Something like 100,000 cases a year that could be treated with this rather than the existing treatments," Dr. Regan said.

Six weeks after the procedure, this 31-year-old flight attendant says she's ready to fly.

"I feel like I've gotten my wings back," Henriquez said.

chasswen 02-09-2007 07:17 PM

rob
yes dr bertagnoli does this procedure.http://www.netplosiv.de/pro-spine/cm...t.php?idcat=30
hope this helps you.
chuck

mmglobal 02-09-2007 07:58 PM

Chuck, the autologous chondrocyte implantation is a different procedure.

In ADCT procedure they harvest nucleus cells during a discectomy. They send these cells to a lab to culture 20 times more than harvested. Months later, they pressure test your annulus. If the annulus holds pressure, they'll insert the freshly cultured nucleus cells. I've seen some pretty impressive films of successful patients.

In the Dascor procedure, they evacuate the disc space endoscopically. They insert a balloon and fill it with a flexible polymer that will remain contained by the balloon and will function as a replacement nucleus. Also interesting technology. I've seen several presentations about it at NASS and SAS. I hope it's as promising as it seems.

Mark

mmglobal 02-23-2007 02:03 AM

I spoke to Dr. Regan today at length about Dascor and other issues. He's already done several cases with good EARLY results. The device is in the pilot phase that only includes 20 patients. There are a few slots left, but there is no way to tell how long they will be available.

We discussed many of the issues related to nucleus replacements and past failures. There is much about the Dascor design that addresses many of these issues. The stringent protocol for the pilot phase is interesting and it will be more interesting to see how the pivotal study will be designed.

More later.

Mark


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